Consumer Safety Officer (Biologics/Blood Bank/Tissue), GS-0696-13


Vacancy ID: 864191   Announcement Number: HHS-FDA-ORA-MP-13-864191   USAJOBS Control Number: 340403200

Social Security Number

Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name.  As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.


Vacancy Identification Number

Enter 864191
1. Title of Job

Consumer Safety Officer (Medical Device/Radiological-MQSA), GS-0696-13
2. Biographic Data

3. E-Mail Address

4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

Are you  a current Food and Drug Administration (FDA) employees with competitive status only?  Competitive status refers to employees who are serving on a career or career conditional appointment.


Are you a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?


Are you eligible for noncompetitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers.  This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.


6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 13.


13

11. Miscellaneous Information

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


01 Yes
02 No
03 Not Applicable

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

If you are applying by the OPM Form 1203-FX, leave this section blank.

15. Dates of Active Duty - Military Service

If you are applying by the OPM Form 1203-FX, leave this section blank.

16. Availability Date

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Select/enter at least one occupational specialty. The specialty code for this position is:


001 COMPETITIVE
002 REASSIGNMENT/NON-COMPETITIVE

21. Geographic Availability

Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:


481730085 Dallas, TX
483280157 Houston, TX
486090029 San Antonio, TX

22. Transition Assistance Plan

If you are applying by the OPM Form 1203-FX, leave this section blank.

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

Your response to the statement below will determine if you meet the area of consideration.

1. I am a current employee of the Food and Drug Administration, Office of Regulatory Affairs.

A. Yes
B. No

Please answer yes or no to statement one. Your response will determine if you are qualified for the GS-13 Consumer Safety Officer (Medical Device/Radiological - MQSA) position.

2. I have at least one year of specialized experience that has equipped me with the particular knowledge, skills and abilities to successfully perform the duties of the position. This experience is related to the work of the position and equivalent to at least GS-12 level in the Federal Service as described in the vacancy announcement.

A. Yes
B. No

3. From the descriptions below, select the one which best describes your education and/or experience and meets the basic qualification requirements for Consumer Safety Officer, GS-0696.

A. I have a degree that included at least 30 semester hours in one or acombination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.
B. I have a combination or education and experience - with courses consisting of at least 30 semester hours in the fields of study previously described, plus appropriate experience or additional education.
C. I do not possess the education and/or experience describe above.

Please answer yes or no to statement two. Your response will determine if you meet the time-in-grade requirement for this position.

4. I have 52 weeks at the GS-12 grade level or above in the Federal Service within 30 days of the announcement closing date.

A. Yes
B. No

For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.  Note: Submission of this electronic questionnaire is certification that all responses are true to the best of your knowledge. Materially false, fictitious, or fraudulent statements or representations are subject to disciplinary action.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

5. Conduct technical, complex, and multi-faceted inspections and in-depth investigations in the area of biologic, blood bank, plasmapheresis and human tissue and tissue based products.

6. Review reports of inspections and investigations for violations and determine the sufficiency of the evidence.

7. Serve as an expert witness in area of expertise in court cases dealing with regulated products.

8. Evaluate and make recommendations on necessary regulatory actions as required.

9. Conduct complex, technical investigations and inspections of blood banks, laboratories and manufacturers of plasma and human tissue and based products.

10. Consult with appropriate personnel to identify the regulatory aspects that have bearing and influence on the decision as to whether violations encountered do or do not render a product a threat.

11. Conduct reviews of previously approved products within a programmatic area  to determine if they meet current scientific safety criteria providing a course of action to resolve any violations if needed.

12. Developed operating policies and procedures to establish and provide program strategies.

13. Review and evaluate a variety of investigative methods within a programmatic area for use in conducting inspections and investigations.

14. Plans,conducts and directs complex inspections and investigations in the  area of biologics, blood banks and human tissue.

15. Communicate directly with various FDA Regional offices, headquarters, state regulatory agencies, and government agencies coordinating investigations and inspections and following up on programmatic issues relating to the national public.

16. Participate in Field workshops and in industry seminars as the most knowledgeable field official in matters relating to biologic products, human tissues and tissue based products.

17. Prepare and maintain reports documenting specific details of a complex, sensitive and critical nature pertaining to legal violations and threats to the public health.

18. Participate in the preparation of guidelines and other official documents.

19. Provide written adequate information involving investigations, inspections, lab test results, and breakdowns of imminent or potential hazards to consumer safety.